Molecular Network Characteristics of Phlegm-heat Syndrome in Ischemic Stroke Based on Multi-omics Integrated Analysis

Sponsor

Dongzhimen Hospital, Beijing (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05626296

Collaborator

(none)

Enrollment

13.5

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The molecular characteristics of ischemic stroke with phlegm-heat syndrome and candidate biomarkers were identified based on multi-omics data. The main purpose of this study is to validate the molecular characteristics and biomarkers of phlegm-heat syndrome in ischemic stroke, and to demonstrate the association of biomarkers with clinical outcomes.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke, Acute

Detailed Description

This is a cohort study in patients with ischemic stroke. The demographic characteristics, TCM syndromes, and other baseline information will be recorded. At the same time, baseline peripheral blood will be collected. These participants will be followed up to 90 days of onset, and 90-day modified Rankin scale (mRS) scores will be assessed. The collected blood samples will be tested by multi-factor detection technology for candidate biomarkers.

Study Design

Study Type:

Observational

Anticipated Enrollment :

24 participants

Observational Model:

Case-Control

Time Perspective:

Other

Official Title:

Molecular Network Characteristics of Phlegm-heat Syndrome in Ischemic Stroke Based on Multi-omics Integrated Analysis

Anticipated Study Start Date :

Nov 14, 2022

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Phlegm-heat syndrome in ischemic stroke Phlegm-heat syndrome: the score of "Phlegm-dampness syndrome" ≥10 with the score of "Internal fire syndrome" ≥10 in Diagnostic Scale for Syndrome Elements of Ischemic Stroke
Non-phlegm-heat syndrome in ischemic stroke Non-phlegm-heat syndrome: the score of "Phlegm-dampness syndrome" <10 with the score of "Internal fire syndrome" <10 in Diagnostic Scale for Syndrome Elements of Ischemic Stroke
Healthy subjects

Outcome Measures

Primary Outcome Measures

Omic biomarkers associated with phelm-heat syndrome in ischemic stroke [baseline]
Sensitivity, specificity, and area under the ROC curve of omic biomarkers of Phlegm-heat syndrome in ischemic stroke.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Acute ischemic stroke, were confirmed by magnetic resonance imaging (MRI).
Symptom onset within 72 hours.
Diagnosis of phlegm-heat syndrome or non-phlegm-heat syndrome.
Male or female ≥ 50 years and ≤ 80 years.
With written informed consent.

Exclusion Criteria:

Planned or already receiving intravenous thrombolysis or endovascular treatment.
Acute infectious diseases or acute exacerbations of chronic diseases within one month before enrollment.
Patients with previous stroke.
Renal or hepatic insufficiency, tumors, immune diseases, severe underlying diseases.
Other conditions that may affect the collection and evaluation of clinical information (e.g., severe aphasia, mental illness).

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Dongzhimen Hospital, Beijing

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ying Gao, Professor, Dongzhimen Hospital, Beijing

ClinicalTrials.gov Identifier:

NCT05626296

Other Study ID Numbers:

82102823-01

First Posted:

Nov 23, 2022

Last Update Posted:

Nov 23, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 23, 2022